BeOne Medicines wins first-in-world nod for Sonrotoclax in China

The approval is backed by data showing deep, durable responses and manageable tolerability

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

GSK reports breakthrough results in chronic hepatitis B trials

Addex spin-out Neurosterix launches Phase 1 trial for novel schizophrenia drug

NTX-253 is a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety

MetaVia’s DA-1726 shows breakthrough weight loss in Phase 1 trial

Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit

Mabwell’s groundbreaking anti-IL-11 antibody enters Phase II trials for pathological scarring

The Phase II study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of 9MW3811 in patients with pathological scarring

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

IRLAB launches Phase Ib Trial of IRL757 for Parkinson’s patients with Apathy

The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain